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Withings gets TGA approval for ECG and Sleep Apnea on latest Smart products

Smart health device company Withings has managed to do something Apple hasn’t been able to do – Approval for the ECG function of their latest smart watch.

Apple announced the Series 4 Apple Watch two years ago, with approval from the USA’s regulator the FDA to use and market the ECG functionality, but here in Australia that was not approved by our Therapeutic Goods Association (TGA) and to this date the ECG isn’t available to Aussie Apple Watch users.

EFTM reached out to the TGA to confirm the Apple Watch is yet to obtain approval in Australia, with a spokesperson saying “As at 29 October 2020 there are no devices included in the ARTG sponsored or manufactured by Apple.”

Many have speculated that the TGA’s process may restrict companies from getting approvals, however that was proven wrong today, with Withings announcing their latest “ScanWatch” has obtained approval from the TGA as a medical device including it’s ECG and Blood Oxygen features.

I can’t overstate what a big deal this is, Apple – the biggest tech company in the world – has not been able to get approval for it’s ECG feature. Withings has.

Withings ScanWatch

Withings call the ScanWatch the “first hybrid Smartwatch with ECG, heart rate and oximeter”. It’s hybrid because it’s an analogue watch on the face of it – pardon the pun, but it’s smart features are built under the hood with a very small screen to show you what function you’re using and output displays for the ECG and oxygen sensors.

Perhaps my favourite feature of the Withings ScanWatch is the battery life – up to 30 days!

Now there are some pretty epic features that could impact your battery life – like the “breathing distrubances” detection. This is the baseline technology for detecting sleep-apnea, which is still pending TGA approval. Once that approval comes, Sleep-Apnea detection will roll out via a software update.

ScanWatch will be available from next week for $479 (38mm) and for $499 (42mm) at JB-Hi Fi.

Mathieu Letombe, CEO of Withings said “We announced ScanWatch earlier this year in Europe to an enthusiastic response. Today, its capabilities to detect heart rhythm disorders as well as to track blood oxygen saturation levels have become even more useful to our users with the COVID-19 pandemic. With the TGA approval granted we are now delighted to make ScanWatch available to customers in Australia, with medical-grade sleep apnoea detection coming in the near future.”

Withings Sleep Analyser

If Sleep Apnea is your concern, that’s where the Withings Sleep Analyser comes in.

This thing is a mat that sits on the slats or bed board underneath your mattress. A cable runs out the side of your bed into a power point.

Setup is via the Withings Health app which initially uses Bluetooth to pair with the Sleep Analyser, from then it’s using your WiFi to send sleep data to your Withings account.

TGA approved to be promoted as a medical device able to give you an accurate assessment of your Sleep Apnea, without having to sign up for an overnight trial with cables connected to you and a computer.

The Sleep Analyser works by listening to your snoring, detecting your movement and measuring all forms of data like your heart rate from you laying on the mattress above it.

In my limited testing thus far, the data is available almost immediately after you get out of bed.

Sleep Analyzer fits under your mattress and will be $199 at JB-Hi Fi from next week.

Withings gets TGA approval for ECG and Sleep Apnea on latest Smart products
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